Executive Search Success Story: Rebuilding Operations and Quality Leadership to Remediate an FDA Warning Letter at a Sterile Injectables CDMO

How JRG Partners executed a confidential, multi-role North American executive search strategy that equipped a sterile injectables contract development and manufacturing organization with the operations, quality, manufacturing science, regulatory, and engineering leadership required to remediate an FDA warning letter, retain pharmaceutical customers, and return the site to approved supply status.

The Challenge

A sterile injectables CDMO received an FDA warning letter citing contamination control failures, inadequate aseptic process validation, data integrity observations, and a quality unit that had not exercised independent authority at its largest facility. Two branded pharmaceutical customers suspended new product transfers, a third issued a notice of breach, and the site’s eligibility to supply products under pending approvals was in question. The chief operating officer and head of quality were removed, and the board required a complete leadership rebuild to execute the remediation plan committed to FDA. Executive leadership identified several critical vulnerabilities threatening the company:

• An FDA warning letter citing contamination control, validation, and data integrity failures
• Vacant operations and quality leadership during remediation with FDA deadlines
• Customer product transfers suspended and a notice of breach from a major pharmaceutical client
• Aseptic processes and media fills requiring revalidation across three facilities
• A quality unit lacking authority, resources, and credibility with regulators and customers
• Pending customer approvals dependent on the site’s compliance status

Recognizing that remediation required leadership with credibility before FDA and pharmaceutical customers, the CEO and board engaged JRG Partners to recruit a Chief Operating Officer, Senior Vice President of Quality, Vice President of Manufacturing Science & Technology, Vice President of Regulatory Affairs & Compliance, and Vice President of Engineering & Validation. The company required an executive search partner with deep CDMO and sterile manufacturing expertise and access to leaders who had led warning letter remediations.

Why They Chose JRG Partners

CDMO Industry Focus

JRG Partners maintains a dedicated practice serving contract development and manufacturing organizations across small molecule, sterile injectables, biologics, and advanced modalities, with deep recruiting expertise in operations, quality, technical, and commercial leadership. This focus ensured an immediate understanding of aseptic manufacturing, FDA remediation, and the leadership profiles that restore regulatory and customer confidence.

Remediation Leadership Experience

Our firm has extensive experience recruiting operations and quality executives who have led FDA warning letter and consent decree remediations at pharmaceutical manufacturing sites.

Multi-Role Execution

Our team specializes in running coordinated operations, quality, technical, regulatory, and engineering searches in parallel, ensuring leaders are selected as a complementary unit aligned to a single remediation plan.

Our Executive Search Strategy

Phase 1 — Remediation Plan Alignment

Our consultants partnered directly with the CEO, board, and outside regulatory counsel to review the warning letter, the committed remediation plan, customer requirements, and facility conditions, defining five executive profiles sequenced to the remediation milestones.

Phase 2 — Talent Identification & Mapping

Our research team performed an extensive talent mapping initiative targeting operations, quality, manufacturing science, regulatory, and engineering executives at CDMOs, pharmaceutical and biologics manufacturers, and sterile manufacturing operations who had led documented warning letter remediations. Over 430 executives were systematically assessed across these sectors.

Phase 3 — Candidate Engagement

Priority during outreach was given to leaders with a documented history of closing FDA warning letters, rebuilding contamination control strategies and aseptic process validation, establishing independent quality units, resolving data integrity findings, and retaining pharmaceutical customers through remediation. Only candidates meeting these strict performance baselines advanced.

Phase 4 — Selection Process

Finalists presented remediation plans to the CEO, board, and regulatory counsel, completed structured leadership assessments, and underwent reference verification focused on quantified regulatory and customer outcomes.

Key Outcomes

• 430+ pharmaceutical manufacturing and quality executive profiles mapped across North America.
• Successfully placed a synchronized leadership tier spanning operations, quality, manufacturing science, regulatory, and engineering within six months.
• Completed aseptic process revalidation across three facilities within nine months.
• Closed all data integrity observations in FDA correspondence.
• Closed the FDA warning letter following a successful reinspection.
• Resumed all suspended customer transfers and secured pending approvals.